Readers of MLO don’t need to be reminded to circle the dates on their calendar: National Medical Laboratory Professionals Week is April 20 to 26. Across the country, clinical labs are celebrating their service to their communities, and getting the word out in creative ways about the essential role that labs play in the nation’s healthcare delivery system.
In 2014, labs face many challenges—technological, regulatory, economic. New models and technologies also offer many opportunities to serve the public better than ever before. Labs are meeting the challenges and embracing the opportunities. Leaders of some of the best clinical labs presented their credentials to MLO by submitting nominations to be the 2014 “Lab of the Year.” We thank all who did.
In honor of the profession and in celebration of Lab Week, the MLO staff is pleased to recognize our choice for Lab of the Year: The Department of Pathology and Laboratory Medicine of Cedars Sinai Medical Center (CSMC) in Los Angeles, CA. We also recognize first- and second-runners up.
What makes a Lab of the Year? MLO asked lab leaders who submitted nominations, most generally, to demonstrate their lab’s contributions to quality patient care. Beyond that, they were asked to describe their labs with regard to customer service, contributions to patient care, teamwork, productivity, efficiency, creativity, quality control, and lab inspection scores. We asked nominators to emphasize what is particularly successful about their lab, in terms of contributing to the success of the larger institution, meeting unaddressed needs, making a difference in people’s lives. We asked them what makes their lab outstanding, and what makes it special. The CSMC lab—and the runners-up as well—offered impressive answers.
Meet CSMC and its lab
Cedars-Sinai Medical Center is one of the largest not-for-profit medical centers in the western United States with 886 licensed beds, more than 10,800 full-time employees, 2,100 physicians on medical staff, and 2,800 nurses. The Department of Pathology and Laboratory Medicine received more than 170,000 outreach laboratory requisitions and performed more than five million tests in fiscal year 2013. The lab has more than 70 MDs and PhDs on staff, and more than 500 employees. Led by Mahul Amin, MD, FCAP, Chairman of the Department, and Kathleen Clark, MHA, MSMT, CLS, Director, Pathology and Laboratory Medicine, it is a busy, vital place. It is also a true center of excellence within its larger institution.
Dr Amin sums up the laboratory’s broadest objective in that institutional context: “The laboratory’s goal is to contribute to the success of the Medical Center and provide our patients with excellence in Clinical Pathology and Anatomic Pathology by contributing to the clinical, research, and education mission of the institution.” He adds, “The department has developed a culture of lifelong learning, enhancing patient care and safety through continuous improvement processes and a quest for innovation.”
The large staff benefits from carefully structured forums for communication. “The meetings we have with our staff as well as with our leadership team are strategic and purposeful,” says Director Clark. Adds Dr. Amin: “We believe in the right quantity and quality of meetings, to get buy-in and involvement from the ground up.”
“We are a goal-oriented, benchmark-driven organization that begins and ends with patient care,” says Dr. Amin. “We are unified by a shared vision.” Department leaders advance the commitment to quality patient care through the lab’s Operational Excellence program. That involves building a foundation for continuous improvement principles and the Institute of Medicine’s six aims for quality: patient safety, timeliness, effectiveness, a patient-centered approach, efficiency, and equity. Other principles include LEAN and Six Sigma. Lab leaders have outlined those objectives in a five-year Strategic Plan and branded the Operational Excellence program as “Cedars-Sinai-PATHway.” This approach complements an ISO-based Quality Management System.
Using those successful strategies, methods, and outcomes, the lab has increased the level of employee involvement. Mandatory online training for all employees covers the 12 Quality System Essentials. A Lean Six Sigma Yellow Belt program trains 50 frontline coaches throughout all sections of the laboratory.
Another core strategy is offering patients and providers innovative technology such as next generation sequencing for cancer, chromosomal microarrays for prenatal diagnoses, MALDI-TOF for rapid diagnosis of infectious disease, and digital pathology for education and research. (The applications of these and other technologies are described below.)
Customer service and patient care
To improve the services provided to patients, nurses, and physicians, the CSMC lab instituted the “Voice of the Customer” initiative. This initiative empowers each laboratory section to pursue improvement projects based upon the customer’s needs. Medical, scientific, and administrative leadership actively engages customers to identify possible areas of improvement. One example: working with nurses and physicians in Labor and Delivery, lab staff identified a group of tests of particular importance in the evaluation of preeclampsia patients. In response, they developed strategies to improve turnaround time, which now averages 30 to 45 minutes. More broadly, 90% of critical values are reported within 15 minutes of testing, with an average of eight minutes
Timeliness of test results is a key component of patient care. TATs for routine inpatient tests average less than 60 minutes, and stat tests average 30 to 45 minutes. In 2013, the lab improved routine Gram stain TAT by 35%. Implementation of the TB-Rifampin PCR assay provides a same-day TB result. Ninety-five percent of inpatient surgical pathology results are reported within two days of collection. During the past year, a dashboard using a Data Warehouse was implemented so TAT can be monitored with large screen monitors.
The lab works with CSMC to contribute to patient care in a wide variety of areas:
- Precision medicine and target therapies. The Molecular Pathology laboratory has validated and launched a Next Generation Sequencing Cancer Panel which will allow conventional and unconventional targeted therapies for patients with unusual cancers not amenable to traditional therapies. “This methodology puts pathologists at the center of patient care,” notes Dr. Amin.
- Tissue examination. The AP laboratory has extended its video and audio connectivity to the operating rooms to improve delivery of care to patients and foster direct communication between the surgeon and the pathologist. New immunohistochemical (IHC) markers have been added to facilitate diagnosis.
- Rapid detection of infectious organisms. The Microbiology section provides timely results by employing methods such as MALDI-TOF and PCR for viral respiratory pathogens. Working with Pharmacy, the lab has developed a blood culture algorithm to improve antibiotic stewardship.
- Ensuring blood safety. The Transfusion Medicine Division has spearheaded a comprehensive blood management program including a Massive Transfusion Protocol to include pre-thawed AB plasma, cryoprecipitate, and platelets, and implemented blood transfusion guidelines in the hospital CPOE system.
- Value-based healthcare and best practices. A new initiative, “CS-Medicine,” calls for pathologists to participate in and promote value-based healthcare, including focus on test utilization and cost-effectiveness, while reducing length of stay and readmission rates. The CS-Medicine program began in 2012, when lab leaders inititated a series of meetings with CSMC clinical and administrative personnel, and has grown to include a number of objectives including avoiding unnecessary repeat testing, consolidating outside testing, improving blood transfusion ordering, and more.
- Hemostasis and coagulation. In 2013, the Coagulation laboratory was restructured; a comprehensive diagnostic program combining Hematopathology, Transfusion Medicine, and Molecular Pathology expertise was created. Thromboelastograph (TEG) instruments were installed in the operating suites to reduce inappropriate blood component utilization for cardiac surgeries and trauma patients.
- Chromosomal microarray. In 2013, the Cytogenetics laboratory implemented prenatal chromosomal microarray analysis as an adjunct to karyotype analysis.
Dr. Amin and Director Clark point to a number of recent initiatives for improved care that required close cooperation with other departments in the hospital, e.g, Nursing. Among these were efforts to reduce contaminated patient samples and mislabeled specimens, and adjustments in procedures related to neonatal testing. Clark instituted a requirement that all managers go on rounds with nurses on a regular basis, and this practice opened the door to significant improvements.
|Aileen Jardeleza, CLSII, performing Free Kappa and Free Lamba testing.|
Teamwork, productivity, and efficiency
Team-based projects have been initiated in each laboratory section. Many sections implement staff “huddles” to increase employee engagement and disseminate important information about operational issues. Huddles, brief stand-up meetings among managers/supervisors and laboratory staff held daily in the work areas, provide a forum for staff to voice suggestions and concerns and see that their voices are being heard.
The Microbiology lab has developed subspecialty bench-based “work-cells” that address anything from workflow and workload to quality improvement. The small-group atmosphere engages lab staff to feel the sense of ownership that is crucial in any effective organization.
In 2013, AP was the first section to use staffing-by-workload analysis, an approach that takes into account incoming specimen volume and staffing for a given period of time; as a result, staff schedules are adjusted according to the projected volume. Similarly, the Microbiology laboratory has seen an increase of more than 7% in productivity by taking into account both specimen volume and staffing needs. This concept is being replicated in other labor-intensive sections of the laboratory such as phlebotomy and accessioning. According to Clark, staffing-by-workload directly impacts TAT, operational performance, cost, and quality.
|Blood donor services at CSMC: optimizing blood collection with automation.|
Also in 2013, the AP Department piloted new concepts in Lean Visual Management using day-by-day and hour-by-hour production charts via white boards prominently posted in the work areas. Employees can see the results of their work in nearly real time, and supervisors report increased employee engagement, teamwork, productivity, and problem-solving. Concurrently, work standards for accessioning, grossing, and histology were adjusted based on input from the frontline workers. In 2014, the lab plans to expand on these concepts and supplement white boards with new Dashboards.
A state-of-art automated hematology analyzer replaced an older model last year, improving productivity and TAT of all hematology tests, and Digital Image Analysis for differential counting of peripheral blood cells was implemented to alleviate the heavy labor burden of manual differentials and allow technologists to spend more time on pathological specimens.
Efficiency and creativity
A major initiative at CSMS has been the restructuring and modernization of all laboratories—approximately 100,000 square feet—to increase efficiency and safety. Numerous projects have demonstrated improved efficiencies and superior outcomes. Efforts in Transfusion Medicine led to a significant reduction in overall operating expenses and resulted in the CSMC Blood Bank being recognized by the University Healthcare Consortium as “Most Improved Blood Bank.” The Blood Bank was able to implement red cell genotyping, which decreased the need to purchase antigen-screen units. Automated refrigerated storage units were installed in the cardiac and liver transplant/trauma ICUs to bring blood closer to the patient care areas.
Using Lean principles of smaller batch sizes and workflow in IHC and AP, the lab was able to deploy employees to different tasks within the same division. IHC converted to fully automated platforms and used Lean 5S to reorganize the laboratory.
In the Core Laboratory, auto-verification implemented for chemistry, hematology, and coagulation was able to decrease TAT by 26% on average for all inpatient tests. Along with early dispatching of phlebotomists, this translated into 98% of all morning labs being reported by 9 am. The Core Laboratory also implemented several test algorithms, including cascades for thyroid, calcium, prostate, and HIV testing. Molecular Pathology, in collaboration with Cytology, undertook a Green Belt project to improve specimen workflow with shared specimens. The number of days to reach 95% completion rate for liquid-based Pap specimens was reduced by 30%.
Laboratory leadership has played a key role in configuring the hospital CPOE system. This resulted in a 40% decrease in Duplicate Orders, 50% reduction in Changed Orders, and 42% reduction in No Specimen Received. Development and active use of a module in the electronic medical record system to elicit physician feedback regarding laboratory services provides lab leaders with input on how to improve operations to better serve clinical care and efficiency. The lab has made creative use of the LIS to develop non-reportable test batteries to track nonconforming events, providing a simple, cost-effective event-tracking system to identify and review problems requiring a root-cause analysis.
Quality control and verification and validation protocols, under Cedars-Sinai PATHway, are consistent with guidelines from the Clinical Laboratory Standards Institute. A notable example of gain was in AP, where QA/QC procedures applied to accessioning processes reduced errors by 70% over two years. The most significant advance in recent years was implementation of an electronic document control system. This system includes step-by-step instructions on routine quality control. Clark asserts that the benefits of this system far outweigh the costs of the computer software.
|Above, Chris Portillo, Team Leader, issuing RBCs to the OR. Left: A microbiologist loads blood culture bottles onto a blood culture system.|
She adds that the lab has established an “Always Ready” culture for biennial CAP inspection preparedness, leveraging automated email and calendar scheduling to make sure that hallmark dates and tasks are clear and achieved. “These improvements have advanced our overall training and competency programs, and regulatory compliance. Technologists have hyperlinked our electronic procedures to the hundreds of CAP checklist questions. Through this initiative, we like to say that we are creating an army of CAP inspectors!”
The Joint Commission National Patient Safety Goals are at the forefront of the lab’s quality program. In hospital benchmarked data, it has a very low mislabeling rate of 0.003%, and has demonstrated 100% hand hygiene for more than 30 consecutive months. “Most importantly,” says Clark, “the level of our commitment to quality patient care throughout all facets of the laboratory and by all employees is demonstrated by zero Phase II deficiencies on the recent external CAP inspection, and zero deficiencies on FDA, FACT, and California inspections.
A core, fundamental belief
Near the end of our conversation with the leaders of the Department of Pathology and Laboratory Medicine of Cedars Sinai Medical Center, the editors of MLO brought up a question that might be in the minds of readers too: Due to its size and its affiliation with a major medical center, is our Lab of the Year a valid model for labs with fewer resources at their disposal? Can smaller labs realistically aspire to achieve what the CSMC lab has accomplished?
Dr. Amin answered that these were fair questions, and acknowledged that the sophisticated technological solutions that his lab had brought in might not be feasible for smaller institutions. But, he added: “Striving for quality, productivity, and efficiency, and being integrally involved in medical decision making, are things that every lab can do; they are not unique to a large institution. At the heart of all we do is a core, fundamental belief in being very active participants in patient care. That is applicable to all labs, irrespective of size.”
We think that is well said—and a good a way to end this “Lab of the Year” article, along with wishing a rewarding Lab Week to all.
First runner-up: Baptist Medical Center Laboratory
|Members of the MS Baptist Medical Center lab leadership team include Jennifer Knight (Lab Manager), Robert Barham (Lab Director), Don Ward (Marketing Representative), and Carolyn Kent (Lab Manager).|
MLO is proud to salute Mississippi Baptist Medical Center Laboratory of Jackson, Mississippi, as first runner-up Lab of the Year. The MBMC Laboratory is part of Baptist Health Systems, which has 3150 employees across three hospitals and sixteen clinics throughout central Mississippi. Baptist performs an impressive 3.7 million lab tests annually. Baptist Laboratory stands out for its commitment to service in the community, its outstanding professional development, and its advanced outreach performance.
Much of Baptist Lab’s success derives from its core culture of striving to provide exceptional care. Baptist launched a program termed “Path to Service Excellence”. This program recognizes employees who go above and beyond their daily work tasks to deliver exemplary customer service to patients, physicians, visitors, and coworkers. In addition Baptist Medical Center recently launched a relationship based-care (RBC) initiative. Relationship-based care is a model of care that places personal relationships among caregivers, patients, and their loved ones at the center of care delivery. Each department within the hospital establishes a unit practice council (UPC) to incorporate and personalize the concepts of RBC at the employee level.
An area in which Baptist Laboratory excels is outreach. The lab has a robust outreach program with more than 160 active accounts. Several smaller area hospitals utilize Baptist Laboratory as their primary reference laboratory. This is in large part due to the technical expertise, as well as the rapid responsiveness, the entire Baptist team provides to these facilities. The outreach department processes more than 10,000 requisitions per month through the program. Baptist provides laboratory testing services at no charge to three local non-profits; these entities provide limited medical services to individuals who are uninsured or underinsured. Baptist believes that benevolence makes wise sense for the medical community at-large.
|Members of the MS Baptist Medical Center Unit Practice Council review process improvement ideas from laboratory staff.|
The laboratory staff is also active in various community and statewide activities. For example, Baptist Health Systems has partnered with organizations working to revitalize the Midtown community in Jackson. Several laboratory employees have participated in activities with two schools in the inner-city community. One laboratorian volunteers her time to read with children at the school. Other staff recently judged science-fair projects for third, fourth, and fifth-grade students and judged state-level competition for students participating in various events with the Health Occupations Students of America (HOSA) organization.
Educational development of laboratory professionals is another section in which Baptist shines. Baptist Laboratory has a School of Medical Technology. The school prides itself on a 100% certification pass rate for its students over the past three years. In addition, all MTs, MLTs, MLSs, CTs, and HTs employed at Baptist are nationally certified. For continuing education that promotes cutting-edge patient care and to maintain certification, Baptist Laboratory offers complimentary continuing education to its employees. These offerings include on-site webinars and lectures on current topics in the field of laboratory medicine.
While exemplary quality control (QC) is demonstrated throughout the laboratory, some areas exceed what is required to maintain a level of quality that far surpasses the norm. Immunohematology performs full AHG cross-matches and starts transfusions with the nursing staff. Part of the transfusion process includes a bedside typing by blood bank staff to confirm patient identity, ABO, and Rh type. Also the core laboratory recently introduced auto-verification in the hematology area with great success. The chemistry section of the lab is following suit with an anticipated auto-verification roll out in 2014.
The lab also has an extensive point-of-care program. Accrediting agencies often require only monthly liquid (external) QC testing for most moderately complex tests. The Baptist point-of-care criteria mandate weekly liquid QC testing in addition to internal control monitoring.
Second runner-up: Creative Testing Solutions
Creative Testing Solutions (CTS), is one of the leading independent blood donor testing organization in the United States, has four donor testing laboratories and is headquartered in Tempe, AZ, with laboratories located in Chicago, IL, Dallas, TX, Phoenix, AZ and Tampa, FL. All are FDA-registered facilities, AABB Accredited and hold current certifications for the Clinical Laboratory Improvement Act (CLIA). In addition to donor specimen testing, the laboratories participate in clinical evaluation of reagents, test kits, and equipment.
The CTS Special Testing Laboratory in Phoenix, AZ performs confirmatory and supplemental testing of donor samples as well as non-donation testing such as donor re-entry, post exposure, and donor follow-up. The Component Quality Control laboratory in Phoenix also provides blood component quality control testing, residual white blood cell (rWBC) counts, Factor VIII and fibrinogen assays, and bacterial detection.
CTS provides computerized sample handling and result reporting that allows clients to better understand when their test results for both donors and patients will be available. The organization has both Blood Bank Technologists and Specialists in Blood Banking schools and offers training to a wide range of applicants, providing career advancement and community growth in fields that have experienced resource shortages
The company actively participates in patient care by providing avenues for testing research and actual tests to its testing community, thus ensuring blood safety. It also provides a quick TAT for testing of platelet products and includes testing for fractionators which provide commercial products for those patients.
The Dallas, Phoenix and Tampa labs came together in 2010, and CTS immediately began seeing advantages. These included the ability to compare a variety of metrics among the constituent entities. Each lab has its own QA Director and QA Specialist who report to a corporate QA group. Metrics used included number of tests/FTE, cost per test per lab, TAT per lab, quality metrics involving DMAIC (Define, Measure, Analyze, Improve and Control), and events and reportable/inspection results per lab. Improvement in efficiency was measurable: for instance, in 2013, the number of events for one of the labs dropped from 0.15 to 0.09 per 100,000 tests performed over eleven months, and efficiency in TAT improved from 75% results reported on time to 91%.
CTS recently changed viral marker vendors to improve testing TAT and to utilize the most current analyzers. Other recent innovations have included participation in the development of new assays for emerging infectious diseases and in clinical trials for new Babesia and dengue blood screening tests.
One of the most valuable things a lab can do is communicate with its internal and external clients. CTS created mechanisms to ensure this occurs on a regular basis. It has a website that allows clients to receive updated information that is specific to them including IR/RR results for their testing and CEU-approved educational information. CTS is also called on to help clients with their own regulatory inspections. Client monthly meetings are another way CTS creates a bond with clients and gains understanding of their often-changing needs.